Companies of Johnson & Johnson is recruiting for a Manager
of Pharmacovigilance (PV) Compliance Operations to
be based in Horsham, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson,
what matters most is helping people live full and healthy lives. We focus on
treating, curing and preventing some of the most devastating and complex
diseases of our time. And we pursue the most promising science, wherever it
might be found.
Janssen Research & Development, LLC discovers and develops
innovative medical solutions to address important unmet medical needs in
oncology, immunology, neuroscience, infectious diseases and vaccines, and
cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more
We are Janssen. Our mission drives us. Our patients inspire us. We
collaborate with the world for the health of everyone in it.
The Manager, PV Compliance Operations is
responsible for oversight of investigation processes associated with delays in
the receipt and/or in the management of adverse event or safety
information. This may include the compliance investigation
processes associated with late Individual Case Safety Reports (ICSRs) submissions
to Health Authorities or delays in receipt of safety information from Janssen
business partners or Janssen Local Operating Companies. The individual will also be responsible for
responses from Janssen to Alliance Partners when compliance documentation is
requested from Janssen. Monitors case
receipt compliance investigations of safety information associated with Local
Operating Companies, ensures that they are completed within SOP timelines and
that appropriate documentation is completed and retained. This person may be
responsible for direct or indirect oversight of J&J employees and vendor
- Performs and/or manages complex compliance
investigations related to Local Operating Companies, Vendors and Alliance
Partners and other complex investigations within Drug Safety as needed
- Driving accuracy and consistency of compliance
investigations and investigation categorizations
- Provides input into corrective/preventative
actions and effectiveness measures for CAPAs as appropriate
- Collecting and analyzing compliance results,
and sharing results with Janssen management, Alliance Partners and vendor
- Works across functional areas to develop and
implement strategies to drive compliance improvements.
- Keys for success in this role include the
ability to develop collaborative partnerships with Alliance Partner and Local
Operating Company colleagues of all levels and to influence without authority
when complex issues or negotiations arise
- Must have the ability to resolve complex
issues independently and to determine when escalation to senior management is
- Ensuring quality of all documentation, driving
process improvements and tracking, trending and presenting trends of late
submission root causes
- Provides input into corrective/preventative actions
and effectiveness measures for late ICSR and Aggregate Report CAPAs and other
compliance related CAPAs as appropriate
- Works closely with Associate
Director, Compliance Operations to implement strategies for compliance
- Interfaces directly with all functions impacting GMO / GMS monitored
compliance metrics (including but not limited to): Case Management; Case
Reporting; Vendor Compliance Points of Contact; PAC; IPV / LSO; LOC; QPPV; 3rd
Party Compliance Contact; GRA; GCO
of Bachelor’s Degree in relevant discipline (Business, Science, Medical,
Operations, etc.) with 8 years of pharmaceutical industry experience or
advanced academic degree with 5 years of pharmaceutical industry experience.
of 5 years’ experience in pharmacovigilance. Prior compliance experience within
PV is not needed.
of GxP requirements is required
of global PV laws and regulations is preferred
to function in a global matrix environment is preferred
communication and writing skills is required
to lead global work streams, drive teams to make decisions, achieve
deliverables and manage and resolve issues independently.
of and experience with multi-cultural working is preferred.
to evaluate processes and procedures against outcomes to identify methods to
improve efficiency, accuracy and compliance.
to utilize appropriate initiative and autonomy in achieving objectives.
track record with negotiation and collaboration is required
experience developing and conducting presentations for different levels of
management; ability to tailor presentations to the appropriate level of detail
Janssen Research & Development, LLC. (6084)Job Function